a study of hs248 in patients with advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: this study is a non-random, open multi-center study this study is a non-random, open multi-center phase i study, aimed at evaluation period research, aimed at in the evaluation phase study, it aims to evaluate the safety, tolerance pk characteristics and preliminary anti-tumor activity of hs248 in patients with advanced solid tumors. the study was divided into 2 phases, including dose escalation and dose expansion。

main purpose: assess the safety and tolerability of hs248 in patients with advanced solid tumors, and determine the maximum tolerated dose (mtd) and/or recommended phase ii dose (rp2d) of hs248. secondary purpose: secondary purpose: assess the pharmacokinetic (pk) profile of hs248 in patients with advanced solid tumors; to evaluate the preliminary antitumor activity of hs248 in patients with advanced solid tumors. preliminary antitumor activity in patients with advanced solid tumors. other purposes: population-based pk (poppk) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description of hs248 in patients with advanced solid tumors pk features in; evaluate the relationship between exposure and efficacy and adverse events (aes) of hs248 in patients with advanced solid tumors, as data permit; to explore the changes of hs248 in myeloid-derived suppressor cells (mdsc) and cd8+ t cells in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. voluntarily participate in this clinical trial, understand and follow the research procedures and voluntarily sign the icf; 2. male or female, age ≥18 when signing the icf; 3. expected survival period ≥ 12 weeks; 4. patients with advanced solid tumors confirmed by histology/cytology, who have progressed through standard treatment, have toxicity intolerance, or have no standard treatment plan (patients with multiple solid tumors are included in the dose-escalation phase, and the population included in the dose-expansion phase will be based on dose escalation phase study data and the potential advantageous population of similar drugs); 5. eastern cooperative oncology group (ecog) physical status score 0-1 exclusion criteria: 1. symptomatic or untreated central nervous system metastasis or primary central nervous system malignancy; 2. other known malignant tumors in the past 5 years, except cured localized tumors, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; 3. previous history of autoimmune diseases, stem cell transplantation or organ transplantation; 4. known drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, persistent extrahepatic obstruction caused by gallstones, cirrhosis or portal hypertension; 5. peptic ulcer and/or gastrointestinal bleeding at present or in the past; 6. gastrointestinal dysfunction that may limit the absorption of the test drug, including motility disorders, malabsorption syndrome or inflammatory bowel disease;